A randomized double-blind trial of intravenous immunoglobulin for pemphigus
A randomized double-blind trial of intravenous immunoglobulin for pemphigus
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DOI：
10.1016/j.jaad.2008.09.052
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发表时间：
2009-04-01
影响因子：
13.8
通讯作者：
Hashimoto, Koji
中科院分区：
文献类型：
--
作者：
Amagai, Masayuki;Ikeda, Shigaku;Hashimoto, Koji
背景：天疱疮是一种罕见的危及生命的顽固性自身免疫性水疱病，由抗桥粒细胞球蛋白自身抗体引起。天疱疮的双盲临床研究一直很难进行，部分原因是在安慰剂组中，当疾病突然出现时，通常必须提供适当的治疗。目的：采用多中心、随机、安慰剂对照、双盲试验，观察连续5天单周期静脉注射大剂量免疫球蛋白(400、200或0 mg/kg/d)对对全身类固醇激素相对耐药的患者的疗效。方法：我们以脱离方案的时间为新的主要终点来评估疗效，以及天疱疮活动度评分、抗桥粒细胞球蛋白酶联免疫吸附分析评分；结果：我们招募了61名寻常型天疱疮或叶型天疱疮患者，这些患者对强的松龙(>；=20 mg/d)无效。与安慰剂组相比，400毫克组的逃脱时间显著延长(P
Background: Pemphigus is a rare life-threatening intractable autoimmune blistering disease caused by IgG autoantibodies to desmogleins. It has been difficult to conduct a double-blind clinical Study for pemphigus partly because, in a placebo group, appropriate treatment often must be provided when the disease flares.Objective: A multicenter, randomized, placebo-controlled, double-blind trial was conducted to investigate the therapeutic effect of a single cycle of high-dose intravenous immunoglobulin (400, 200, or 0 mg/kg/d) administered over 5 consecutive days in patients relatively resistant to systemic steroids.Methods: We evaluated efficacy with time to escape from the protocol as a novel primary end point, and pemphigus activity score, antidesmoglein enzyme-linked immunosorbent assay scores;, and safety as secondary end points.Results: We enrolled 61 patients with pemphigus vulgaris or pemphigus foliaceus who did not respond to prednisolone (>= 20 mg/d). Time to escape from the protocol was significantly prolonged in the 400-mg group compared with the placebo group (P